Peak SE Primer Kits (4 syringes per kit) manufactured by… recallZ-1822-2012 · Ultradent Products, Inc. · initiated May 24, 2012
Class II Terminated All recalls posted in June 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ultradent Products, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures.
FDA root cause category: Labeling mix-ups
What the company is doing
Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.
Recall details
- Recall number
- Z-1822-2012
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 24, 2012
- Posted by the FDA
- Jun 18, 2012
- Recalling firm
- Ultradent Products, Inc.
- Quantity
- 172 kits (4 syringes per kit)
- Product code
- KLE
- FDA submissions
- K063558
- Distribution
- Worldwide Distribution.
Product description
Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite.
Code information (models, lots, serial numbers)
Lot number: B6Z4K.
Other devices under the same FDA submission
1 device cleared under K063558 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Peak SE 5135Ultradent Products, Inc. · AGENT, TOOTH BONDING, RESIN1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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